The lack of a drug recall law in India

• Abbot, a multinational pharmaceutical company, published a public notice in newspapers to alert people about a mislabelled batch of medicine that it had inadvertently shipped to the market.

Key-highlights

• Since 1976, India has been considering enacting a mandatory recall law for defective medications; however, no such law exists to this day, requiring such medicine to be removed off the market.
• People, including children, are probably likely dying or suffering from bad health consequences as a result of poor pharmaceuticals remaining on the market for too long.
• Hundreds of medications flunk random testing in government laboratories every month.

Is there a drug recall law in India?

• The difference in behaviour between India and the U.S. is due to the lack of a mandatory recall law for substandard drugs.
• In 1976, the Drugs Consultative Committee discussed the issue of drug recalls, but no law exists that mandates such medicine be removed from the market.
• Since then, the issue has come up repeatedly in regulatory meetings, but none of them resulted in amendments to the Drugs and Cosmetics Act to create a mandatory recall mechanism.
• In 2012, certain recall guidelines were published by the CDSCO, but they lacked the force of law.

Why is there no recall law?

• The Drug Regulation Section of the Union Health Ministry is not up to the task of tackling complex drug regulatory issues due to apathy, lack of expertise and a greater interest in enabling the growth of the pharmaceutical industry.
• India's highly fragmented regulatory structure, with each State having its own drug regulator, makes it difficult to create an effective recall mechanism.
• India's drug regulators are aware that a mandatory drug recall system will bring public attention to the state of affairs in India's pharmaceutical industry.

What happens when substandard drugs are not recalled?

• People, including children, are almost certainly dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
• Every month, dozens of drugs fail random-testing in government laboratories. Ideally, these drugs will be necessarily recalled in a transparent manner, with the people being informed of the failures.
  • If this were to actually happen in India, the people would be flooded with alerts on an almost daily basis, which then would increase the pressure on drug regulators to institute extensive reforms.
  • If the bureaucracy’s intention is to avoid accountability, it might prefer to keep quiet and let substandard drugs, even those with dangerous consequences for consumers, circulate in the market.
• This has been their modus operandi for decades, until recently, when drug failures overseas brought attention to this issue. Yet nothing has changed on the ground.